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MatrixRIB 04.501.004Recalls & reported problems

Synthes GmbH · TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 & 5 · Class 2 · Implant

All models of MatrixRIB (31)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587016986), received between Jul 19, 2022 and Dec 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Device-Device Incompatibility1

Patient problems

  • Dyspnea1
  • No Clinical Signs, Symptoms or Conditions1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(3) 2023, THE PLATES IN QUESTION WERE REMOVED FROM A PATIENT IN WHICH THE FRACTURES WERE COMPLETELY HEALED. THE PLATES WERE ORIGINALLY IMPLANTED APPROXIMATELY 15 YEARS AGO. THE PLATES AND SCREWS WERE NOT BROKEN, THE PATIENT WANTED THE IMPLANTS REMOVED BECAUSE THEY FELT LIKE THEY COULDN¿T TAKE DEEP BREATHS. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 & 5. THIS IS REPORT 2 OF 7 FOR (B)(4).

    Patient problems: Dyspnea

    MAUDE report 18356726 ↗
  • InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2023, A RIB PLATE WAS EXPLANTED. THE PLATES WERE AROUND THE PATIENT, AND WERE INFECTED SO THEY HAD TO GET REMOVED. PLATES WERE ORIGINALLY IMPLANTED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 & 5. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 16311604 ↗
  • MalfunctionJul 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE SURGEON WAS USING THE MATRIXRIB SYSTEM WITH THE MATRIX PRODRIVEII TO IMPLANT A PLATE AND SCREWS ON A FRACTURED RIB. THE PLATE SLIPPED OFF THE RIB SLIGHTLY AFTER HE INSERTED THE FIRST SCREW. HE COULD NOT REMOVE THE SCREW AS IT WAS LODGED IN THE PLATE. WHEN HE WENT TO INSERT THE SECOND SCREW TO SEE IF HE COULD REPOSITION THE PLATE, IT CAUSED A SPLINTERING OF THE RIB AND WAS STILL OFF POSITION. HE SAID THE BONE WAS OSTEOPOROTIC. HE TRIED TO REMOVE THE SECOND SCREW AND IT TOO WAS STUCK IN THE PLATE. HE WAS ABLE TO DISENGAGE THE PLATE AND SCREWS FROM THE BONE WITH THE SCREWS INTACT IN THE PLATE AND UNABLE TO BE REMOVED. HE ENDED UP USING A COMPETITIVE SYSTEM THAT HE WAS MORE FAMILIAR WITH. THIS IS NOT THE FIRST TIME THAT HE HAS TRIED TO REMOVE THE SCREW ONCE INSERTED AND WAS UNSUCCESSFUL. THIS REPORT IS FOR A TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR RIGHT RIBS 4 & 5. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15052945 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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